Kornimate/medical-research-clean huggingface dataset:
bioequivalence of two novolog® formulations in subjects with type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in the united states of america (usa). the aim of this trial is to evaluate the clinical performance of two formulations of insulin aspart (novolog®) in subjects with type 1 diabetes.


Eligibility criteria:
inclusion criteria: * subjects with type 1 diabetes treated with insulin for at least 12 months * bmi (body mass index) between 18.0-29.0 kg/m\^2 * negative fasting c-peptide (below or equal to 0.6 ng/ml) * hba1c (glycosylated haemoglobin a1c) below or equal to 10.0% * current treatment with insulin below or equal to 1.2 u/kg/day * subject should be in good health based on medical history, physical examination and routine laboratory data exclusion criteria: * any known/suspected allergies to trial medication or similar products/devices * a subject who has proliferative retinopathy or maculopathy, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the investigator * clinically significant active disease of any kind * recurrent major hypoglycemia or hypoglycemic unawareness, as judged by the investigator * blood donation (more than 500 ml) within the previous 9 weeks
fibrin for chronic multi-level discogenic low back pain

Conditions: Low Back Pain; Disc Disease; Disc Degeneration; Radiculopathy; Annular Disc Tear

Summary: intra-annular injections of non-autologous fibrin for moderate to severe chronic low back pain (lbp).

the purpose of this study is to analyze data available in the pis regenerative orthobiologics registry (ror) and corresponding patient charts that will either support or refute the efficacy of intra-annular fibrin as treatment for moderate to severe low back pain. additionally, we seek to retrospectively identify possible predisposing factors that are correlated with positive outcomes with respect to patient-reported pain and function.

Eligibility criteria:
inclusion criteria: * recipient of intra-annular fibrin injection for annular defects identified radographically and by annulogram exclusion criteria: * scoliosis greater than 20 degrees * spondylolysis * spondylolisthesis greater than grade 1 * disc extrusion * disc herniations or bulges \> 4mm causing severe stenosis * prior lumbar surgery or intradiscal procedure (i.e. intradiscal electrothermal therapy, nucleoplasty) * cauda equina syndrome * active malignancy or tumor as source of symptoms * evidence of prior lumbar vertebral body fracture or trauma * foraminal stenosis at the affected levels resulting in severe thecal sac compression * dynamic instability on lumbar flexion/extension radiographs * positive response to diagnostic medial branch block or facet joint injection or sacroiliac joint injection * known bleeding disorder * known or suspected hypersensitivity or allergy to drugs or components of the fibrin sealant, including aprotinin, used in the procedure * presence of ferromagnetic implants that would interfere with mri evaluations * active or pending workers' compensation claims or other litigation related to the condition. * pregnant or plans to become pregnant over the course of study participation (2 years)

Keywords: non-autologous fibrin minimally invasive injections intervertebral disc annulus fibrosus sciatica
use of standardized algorithm for the management of epidural analgesia for labor and delivery

Conditions: Labor Pain

Summary: programmed intermittent epidural bolus (pieb) has become a standard technique for labour analgesia in many departments of anesthesia. advantages to the former standard of care, continued epidural infusion (cei), include reduced analgesic consumption , better maternal satisfaction and less occurrence of motor block . at mount sinai hospital, the introduction of a bundle of changes in the management of labor analgesia including the use of pieb, has resulted in an improvement of the quality of labor analgesia. this bundle of changes included labor catheter placement more often at l2/l3 interspace, more frequent use of fentanyl in the epidural loading dose, the implementation of a pieb regimen and an increase in hourly baseline offer of local anesthetic. a recent before-and-after study conducted by the investigators, comparing the current practice with the previous practice, which was based on cei, identified that the incidence of women experiencing pain \>3 (scale 0-10) (40% vs 30%) and the number of nurse-administered top-ups (24% vs 3%) were significantly reduced. however, despite that significant improvement, some 30% of women undergoing epidural analgesia still experience pain nrs \>3 (nrs scale 0-10) during either first or second stage of labor. although the health care team attempts to manage epidurals as standardized as possible, there is some variation in practice resulting from the many stakeholders involved in the labor analgesia management, including anesthesiologists, obstetricians, nurses and patients. the investigators hypothesized that our most recent results may be explained by the lack of standardization of the management of epidural analgesia and that a standardized epidural catheter placement and a management algorithm may improve the efficacy of our epidural analgesia regimen. the aim of this pilot study is to test the feasibility and efficacy of the use of a standardized algorithm for the management of labor epidural analgesia based on a pieb regimen.


Eligibility criteria:
inclusion criteria: * request for epidural analgesia during labor * asa physical status ii and iii exclusion criteria: * patients requiring change in anesthetic management due to comorbidities or complications before initiation of epidural analgesia maintenance will be excluded. * refusal to give written informed consent

Keywords: programmed intermittent epidural bolus epidural analgesia labor epidural
cancer screening and prevention program for high risk women

Conditions: Ovarian Cancer; Breast Cancer

Summary: the purpose of this study is to collect information from a large group of women who may have a greater chance to develop cancer because of their own personal history of cancer or because of their family history of cancer.

the objectives of this study are to be a resource of information on women's cancers, including the availability of a genetics counselor for women at risk for hereditary cancer, especially ovarian cancer; to provide referrals for diagnostic tests and appropriate clinics involved in early detection of cancer; to provide access to clinical trials and investigational screening methods in cancer early detection and prevention, whenever applicable; to provide women with educational materials; to develop a database of information compiled from the questionnaires and clinics for use in future studies; to create a registry of family history data from women of diverse racial and ethnic backgrounds who attend our clinic, i.e. who perceive themselves to be at increased risk of breast or gynecologic cancers.women that participate in the study will be interviewed and asked to fill out a questionnaire. an assessment will then be made based on their information. based on this assessment, women will be referred to the appropriate clinic or for diagnostic testing or provided with information regarding available protocol studies.

Eligibility criteria:
inclusion criteria: * female or male over the age of 18. * patients who have a family history of breast and or ovarian cancer. * patients who have had a personal history of breast and or ovarian cancer or who themselves or a relative have positive genetic markers for breast or ovarian cancer. * patients who seek medical screening and risk assessment for perceived increased risk of breast or ovarian cancer. exclusion criteria: * women with psychiatric, psychological or other conditions which prevent fully informed consent. * patients seeking medical attention not related to the purposes of this protocol, (e.g. those seeking treatment of a known cancer). * women with a history of any medical condition, which places the subject at risk, related to the need for donating blood for research purposes, (e.g., chronic infectious diseases, severe anemia, or hemophilia).

Keywords: screening early detection prevention cancer high risk ovarian cancer breast cancer
interventions for moderate malnutrition in pregnancy

Conditions: Pregnancy; Moderate Malnutrition

Summary: malnutrition during pregnancy is more common in poor women in the developing world due to inadequate dietary intake combined with increased nutrient requirements; pregnancy risk is more consequential than among other demographic groups with increased risk of maternal and infant mortality and the lifelong effects of fetal malnutrition. the benefits of treating moderate malnutrition during pregnancy remain largely undocumented. this study tests the hypothesis that providing either a fortified flour or fortified paste-based supplementary food designed to replete the nutrient deficits during pregnancy will result in improved maternal nutritional recovery rates and higher infant birth weights and lengths. this study is a randomized, controlled clinical trial of 3 supplementary foods in 1800 moderately malnourished malawian women who are pregnant. subjects will receive one of 3 food rations: 1) a ready-to-use supplementary food formulated to deliver about 200% of the recommended daily allowance (rda) of most micronutrients in pregnancy (rusf-p), 2) corn soy blend with a multiple micronutrient tablet chosen to deliver about 200% of the rda of most micronutrients (csb-p) or 3), the standard of care which is a corn soy blend with supplementary iron and folic acid (csb), delivering between 0-350% of the rda. subjects will receive the supplementary food until they recover from mam. the outcome of the pregnancy and maternal nutritional status will be followed until 3 months after delivery.


Eligibility criteria:
inclusion criteria: * pregnant and consenting to study participation and hiv testing (if not already performed) * mid-upper-arm circumference (muac) ≤ 23 cm * planning to stay in the area and attend the clinic during pregnancy and for 3 months post partum exclusion criteria: * pregnancy complications such as gestational diabetes, pre-eclampsia, hypertension * severe anemia (hg \<7.0 mg/dl) * severe malnutrition * under 18 years of age * over estimated 35 weeks of gestation
immune response to covid-19 vaccine in multiple sclerosis patients treated with teriflunomide and alemtuzumab

Conditions: Multiple Sclerosis

Summary: phase iv, 3-armed, prospective, open-label, single-center, israeli study, examining the response to sars-cov-2 vaccination in 30 teriflunomide-, 10 alemtuzumab-treated patients, and 30 age-matched (for the teriflunomide group) untreated ms patients. treatments will be administered according to common local practice. demographic, clinical, treatment-related and covid-19-related data will be collected. blood samples will be drawn for each participant at baseline (before covid-19 vaccination), and at 1, 3, 6, (and possibly 12) months post 2nd dose of covid-19 vaccine. humoral, b-cell and t-cell responses will be evaluated.


Eligibility criteria:
inclusion criteria: (1) diagnosis of multiple sclerosis (ms) according to 2017 mcdonald criteria. (2) age \>=18 years. (3) treatment with teriflunomide for at least 6 months/or 4 to 18 months after the last course treatment with alemtuzumab/or untreated. (4) signed written informed consent. exclusion criteria: (1) cognitive decline that precludes understanding the study procedures.

Keywords: multiple sclerosis covid-19 vaccination teriflunomide (aubagio) alemtuzumab (lemtrada) immune responses igg b-cells t-cells
hysteroscopic monopolar and bipolar resection

Conditions: Menorrhagia; Fibroid; Polyps

Summary: the aim of the study is to evaluate bipolar equipment versus monopolar, and to see if there is any differences between the two types of bipolar equipment espescially regading both safety and effect.

* trial design: a prospective randomised study with three arms, one arm with monopolar surgery and two different arms with bipolar surgery. its a one center study. * trial population: pre-or perimenopausal women reffered to our clinic with bleeding disorders and were we plan to do endometrial resection. patients with a bleeding disorder due to fibroids type 0 and 1 will be included and patients with polyps were endometrial resection is planned at the same time will also be included. * preoperative selection: the fibroids will be mapped using transvaginal ultrasound according to the classification esge. type 0 and 1 fibroids will be included. diameter of the fibroid must not extend 4cm. the endometrium size double layer will be recorded. uterine size anetrior /posterior diameter, longitudinal diameter (cavity; top fundal to isthmus) will be measured. were polyps are included these will be measured; length and width. higham score (pbac), se-hgb, ferritin, fsh and oestradiol will be documented at all visits. menstrual pain will be documented due to a vas-scale. * treatment regimen:randomisation in blocs of 20 between monopolar and two types of bipolar surgery. * surgical technique: the cervical canal will be dilated to hegar 10 or 11 and a rigid resectoscope ch. 26 is passed to the uterine cavity. glycine 1,5% or saline (baxter) is infused to irrigate the uterine cavity (iglesias technique) automatic pressure cuff maintains an infusion pressure of 100mm hg and suction 10-15mmhg is applied to the outflow tube in order to achieve a sufficient flow.fibroids type 0 and 1 are resected in total if possible or flush to the plane of the uterine wall. the tissue chips are removed at intervals by currette and forceps. the operation will be performed by experienced surgeons. * primary response variables: safety is our primary response variable. fluid absorption and lowering of se-sodium will be analysed. these parameters are the only objective parameters which can tell us about safety. nausea will be reorded on a vas-scale. * secondary resonse variables: operating time, tissue removed, easisness of operation, levels of vaginal bleeding measured by the methosd of hgham(pbac)before and at follow up. after 6 month and one year we will look at secondary intervention like repeated resection or hysterectomy.

Eligibility criteria:
inclusion criteria:-pre-or perimenopausal women with a bleeding disorder with or without fibroids or polyps - exclusion criteria:-postmenopausal patient. infertility. additional condition requiring treatment detected during examination. malignancy or atypical hyperplasia detected by histological examination. -

Keywords: hysteroscopic resection menorrhagia fibroids polyps
great occipital nerve block using different approach

Conditions: Pain, Chronic

Summary: great occipital nerve (gon) block is commonly applied for the pain management of occipital neuralgia, migraine, and cervicogenic headache. the gon orginates from the medial branch of the dorsal ramus of the c2 spinal nerve with variable contribution from the c3 dorsal ramus. after emerging from the suboccipital triangle, the nerve courses cephalad in an oblique trajectory between the semispinalis capitis (sc) and obliqus capitis inferior (oci) muscles. this area was recognized as a potential location for gon injury. the nerve then passes through the trapezius muscle and courses medial to the occipital artery as it ascends to innervate the posterior scalp. many practitioners perform gon injections using a conventional approach, relying solely on superficial bone-based anatomic landmarks to infiltrate local anesthetic and corticosteroid around the nerve at the level of the superior nuchal line. some clinicians also use fluoroscopy to confirm the location of bony landmarks. the ambiguity of these injections poses a risk of anesthetizing adjacent structures or injecting into vessels, such as the occipital artery. very limited research has been done to quantify the risk of these injections, but a complication rate of 5% to 10% has been reported, including headache, dizziness, blurred vision, and syncope. ultrasound guidance is increasingly used to mitigate these risks and improve the efficacy of gon injections. multiple studies have demonstrated successful ultrasound-guided gon blockade at the superior nuchal line and improvement in pain scores compared with nonguided injections. c2 level gon block using ultrasound targets interfascial plane between oci and sc muscles. however, a pain physician who begins ultrasound guided injections migth feel very difficult targeting interfascial plane exactly. since gon orginiates from deep space of suboccipital triangle, it is expected that injection within oci muscle might have similar effect with the effect of injection into interfascial plane. we assume that if the local anesthetics is injected within oci muscle, the effect of gon block will be generated by the diffusion of injected local anesthetics.


Eligibility criteria:
inclusion criteria: * cervicogenic headache * migraine * occipital neuralgia exclusion criteria: * bilateral headache * cervical spine surgery within 1 year before * loss of sensory sensation at the dermatome of gon innervation * anatomical defect at the region of procedure * coagulopathy * pregnancy or breast feeding * allergy to local anesthetics
refining and testing the electronic social network assessment program (esnap)

Conditions: Brain Cancer

Summary: the purpose of the study is to learn more about neuro-oncology caregivers' quality of life and how friends and families help neuro-oncology cancer caregivers at different times during treatment.

former aim 1: refine esnap data-gathering and visualization prototypes based on evaluations of user experience, including usability, satisfaction and applicability. the refining process was completed at the university of utah. aim 2: test the feasibility of implementing esnap in a neuro-oncology clinical setting and collect preliminary effectiveness data of esnap on family caregiver outcomes, including quality of life and stress, and mediators (family caregiver social support utilization and burden). the feasibility process will take place at moffitt cancer center. this study will be a 2x2 longitudinal design. caregivers of primary brain tumor patients will be compared to caregivers of patients with secondary brain tumors (brain metastases) to determine if there is something unique about the cancer-specific duties of primary versus secondary brain tumors that could impact the effectiveness of the esnap application. an intervention group will be compared to a control group for both types of caregivers. participants will be randomized 2:1 for the intervention and control. all caregivers will be followed for 6 weeks and will be asked to complete questionnaires at 3 time points; caregivers in the intervention group will also be asked to use the esnap application at time 1, which will be available to them for the duration of the study.

Eligibility criteria:
inclusion criteria: * family caregiver of a patient with primary or secondary brain tumor * age 18 years or older * able to speak and write english exclusion criteria: * does not meet the inclusion criteria

Keywords: brain nervous system neuro-oncology caregivers cancer patient family caregivers brain tumors quality of life stress social support feasibility electronic social network assessment program (esnap)
clinical trial to demonstrate that the dual laser therapy is effective for the treatment of vulvar lichen sclerosus

Conditions: Chronic Skin Disease; Vulvar Lichen Sclerosus

Summary: the aim of this study is to test a new, minimally invasive dual laser technique to treat vulvar lichen sclerosus. efficacy and safety of the thermal non-ablative nd:yag laser and the ablative er:yag laser is determined and compared to the current standard treatment with high dose steroids. the hypothesis is that laser therapy is effective and similar to standard steroid therapy.

lichen sclerosus (ls) is a chronic inflammatory skin disease that usually involves the anogenital area where it causes itching and burning pain, pain during sexual intercourse, and anal or genital bleeding due to fissuring of the damaged tissue. in this study a treatment with dual laser application combining thermal non-ablative nd:yag with ablative er:yag laser is used to reduce the symptoms of ls. results will be compared to the standard therapy with topical steroid cream.

Eligibility criteria:
inclusion criteria: * diagnosis of vulvar lichen sclerosus * clinical ls score ≥ 4 exclusion criteria: * concomitant steroid, calcineurin inhibitor or any other topical or systemic treatment for ls * \< 3 months since start of vaginal estrogen treatment * malignant disease as the cause of the vulval symptoms * bmi \> 35 kg/m² * acute infection (fungal, bacterial, viral) of the vulva, vagina or bladder * presence of contraindications for the laser treatment or topical steroid treatment
safety and efficacy study of her2/neu (e75) vaccine in node-positive breast cancer patients

Conditions: Breast Cancer

Summary: the purposes of this study are the following: 1. to assess safety and document local and systemic toxicity to the peptide vaccine (e75) 2. to determine maximum tolerated dose (mtd) and optimal biologic dose (obd) for the peptide vaccine 3. to evaluate the in vivo cellular immune response to the peptide vaccine 4. to evaluate time to recurrence in the vaccinated patients vs. matched controls

breast cancer is the most common malignancy and second most common cause of cancer-specific death among women in the united states. despite advances in the diagnosis and treatment of breast cancer, one third of the women who develop the disease will die of the disease, accounting for approximately 46,300 deaths/year. while good primary therapies are available to treat early stage breast cancer, there is a substantial failure rate to these therapies in more advanced disease. advances in the understanding of the immune response to cancer have lead to the genesis of immunotherapeutic approaches. specifically, the development of anti-cancer vaccines holds promise as an adjuvant and preventive therapy for patients after both primary surgical and medical treatment for breast cancer, but who are at a high risk for recurrence. patients with greater than four lymph nodes positive have an 87% chance of recurrence post standard surgical and medical therapies at 10 years. while patients with hormone receptor positive tumors have the option to undergo hormonal therapy, recurrence is especially high among estrogen receptor/progesterone receptor (er/pr) negative patients. for these patients, currently there is no good treatment option after completion of primary therapy; close surveillance and watchful waiting is the standard. it is this population of patients that a vaccine strategy to induce cellular immunity would target. we propose to vaccinate these patients with an immunogenic peptide from the her2/neu protein. if successful, this vaccine strategy could be utilized as an adjuvant to currently accepted first line therapy in future clinical trials.

Eligibility criteria:
inclusion criteria: 1. her2/neu expressing tumor 2. hla-a2+ and/or hla-a3+ to receive the vaccine. hla-a2- and/or hla-a3- patients will be eligible to be included in the control group. 3. immunologically intact with a good performance status 4. identified as being high or intermediate risk for recurrence 5. without evidence of disease 6. completion of all standard first-line therapies (but may still be on hormonal therapy) exclusion criteria: 1. tumor does not express her2/neu 2. not hla-a2+ and/or hla-a3+ 3. anergic 4. receiving immunosuppressive therapy 5. in poor health (karnofsky \ 2 and tbili \>1.5 and creatinine\>2) 6. pregnant (beta hcg+) 7. metastatic disease or have refused standard therapies 8. patients enrolled in other experimental protocols may enroll to this study only with the permission of the other study pi.

Keywords: breast cancer